{
 "query": "esketamine",
 "ingredient": "esketamine",
 "slug": "esketamine",
 "rxcui": "2119365",
 "brands": [
  "Spravato"
 ],
 "names": [
  "esketamine",
  "esketamine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": {
  "total": 18675,
  "serious": 13217,
  "death": 757,
  "hospitalization": 3539,
  "primary_suspect": 18646,
  "top_reactions": [
   [
    "Dissociation",
    3779
   ],
   [
    "Sedation",
    2729
   ],
   [
    "Suicidal Ideation",
    1468
   ],
   [
    "Drug Ineffective",
    1148
   ],
   [
    "Nausea",
    977
   ],
   [
    "Depression",
    930
   ],
   [
    "Hypertension",
    870
   ],
   [
    "Product Dose Omission Issue",
    804
   ],
   [
    "Hospitalisation",
    792
   ],
   [
    "Anxiety",
    771
   ],
   [
    "Vomiting",
    742
   ],
   [
    "Dizziness",
    668
   ],
   [
    "Blood Pressure Increased",
    573
   ],
   [
    "Feeling Abnormal",
    511
   ],
   [
    "Off Label Use",
    454
   ]
  ],
  "by_year": {
   "2019": 821,
   "2020": 1087,
   "2021": 1353,
   "2022": 1590,
   "2023": 2235,
   "2024": 3341,
   "2025": 6238,
   "2026": 1971
  },
  "by_year_primary": {
   "2019": 821,
   "2020": 1087,
   "2021": 1353,
   "2022": 1585,
   "2023": 2229,
   "2024": 3334,
   "2025": 6229,
   "2026": 1969
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20190305",
  "rems": true,
  "rems_last": "20260624",
  "labeling_supplements": 6,
  "labeling_recent": 4,
  "sponsors": [
   "JANSSEN PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/05/2019"
 },
 "trials": {
  "total": 359,
  "completed": 144,
  "terminated": 19,
  "with_results": 23,
  "industry": 59,
  "phase3": 30,
  "results_share": 0.1597222222222222,
  "terminated_share": 0.052924791086350974
 },
 "pubmed": {
  "rct": 349,
  "meta": 134,
  "recent_rct": 330,
  "cochrane": [
   {
    "pmid": "42610490",
    "title": "Ketamine and esketamine for postoperative analgesia in gynaecological surgery",
    "year": "2026"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 6147423.09,
  "records": 47112,
  "by_name": [
   [
    "Spravato",
    6147423.09
   ]
  ],
  "names_checked": [
   "esketamine",
   "Spravato"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 84544,
  "beneficiaries": 5542,
  "spend": 128139292.67,
  "by_brand": [
   {
    "brand": "Spravato",
    "claims": 84544,
    "per_claim": 1515.6521181,
    "is_generic": false
   }
  ],
  "per_claim": 1515.652118068698
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "esketamine"
  ],
  "reason": "Esketamine nasal spray is authorised for use in \u201ctreatment-resistant\u201d depression and depression with a high risk of suicide, but its efficacy is highly uncertain. Its neuropsychiatric adverse effects are common and include dissociative symptoms. An increased risk of suicide was reported in the weeks following treatment. Addiction and misuse are likely (Prescrire Int n\u00b0 222, 238; Rev Prescrire n\u00b0 494). In both of these difficult clinical situations, it is more prudent to consider other less dangerous options, even if their efficacy is uncertain, for example: psychotherapy, sometimes with hospit...",
  "edition": "2026",
  "qualifier": "esketamine nasal spray",
  "qualified": true,
  "matched": "esketamine"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "Prescrire lists one form only (esketamine nasal spray) as a drug to avoid; shown for context, no score effect",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 71,
   "letter": "C",
   "why": [
    "349 randomized trials and 134 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 16% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "REMS program in force (-10)",
    "4 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $6,147,423 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are dissociation, sedation, suicidal ideation. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}